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On 15 January 2025, Formycon and Fresenius Kabi announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), for moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. This closely follows the Canadian approval of both subcutaneous and intravenous formulations of FYB202/Otulfi® on 8 January 2025, for the same indications. FYB202/Otulfi® was approved in Europe and the US in September 2024. It is being commercialised in the US, Canada and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fresenius in February 2023. Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America. In March 2024, Formycon and Fresenius announced they reached a settlement with J&J/Janssen regarding the commercialisation of FYB202/Otulfi® in Europe and Canada. This followed a US settlement in August 2023, enabling US launch of FYB202 “no later than 15 April 2025”. The agreed launch dates for FYB202 in the UK and Canada remain confidential. We reported on 26 August 2024 that JAMP had filed an application in the Canadian Competition Tribunal seeking leave to bring an action under the Competition Act regarding Stelara® (ustekinumab). JAMP alleged that Janssen had abused its dominant market position, in contravention of section 79 of the Competition Act by “…gam[ing] the pharmaceutical regulatory system and use[ing] sham litigation to disincentivize rivals from launching their own ustekinumab drugs”. JAMP’s application was the first leave application under the Competition Act’s abuse of dominance provisions to be determined by the Tribunal since the 2022 amendments allowed private parties to seek leave to bring such applications. On 20 November 2024, the Canadian Competition Tribunal dismissed JAMP’s application for leave to bring an action under the Competition Act. The Tribunal held that JAMP’s complaint failed due to a lack of “cogent” evidence to support its allegations that: In March this year, JAMP launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada. The Alvotech-developed Jamteki™ was approved by Health Canada in November 2023. The March 2024 launch followed a settlement between Alvotech and J&J in February 2024 regarding ustekinumab. On 29 October 2024, the Canadian Federal Court dismissed Janssen’s motion to add an infringement counterclaim against Samsung Bioepis in existing patent proceedings. Samsung Bioepis commenced proceedings against Janssen seeking to impeach (invalidate) Janssen’s CA Patent 3,113,837 for Stelara® (ustekinumab) in November 2023. Samsung commenced the impeachment proceedings as an interested person, on the basis that it had filed a submission for a notice of compliance (NOC) for Pyzchiva®, biosimilar to Stelara® (ustekinumab). Samsung received an NOC for Pyzchiva® in August 2024. At that time, Health Canada published a product monograph for Pyzchiva®, which listed Sandoz as a distributor of Pyzchiva®. The Federal Court dismissed Janssen’s motion to add an infringement counterclaim because it was not satisfied that the proposed pleading was adequately particularised, and considered that it did not disclose a reasonable cause of action. The Court stated that, “considering the allegations of direct and induced infringement, both individually and collectively, it is apparent that Janssen does not know what Samsung and Sandoz are presently doing with Pyzchiva beyond obtaining regulatory approval, but is hoping to use the discovery process to find out. This is not a proper pleading”. Ahead of Samsung Bioepis and Sandoz in Canada with ustekinumab biosimilars are: JAMP who launched the Alvotech developed first biosimilar Jameteki™ on 1 March 2024, Amgen who launched Wezlana™ on 4 March 2024 and Celltrion who reported on 31 July 2024 its Canadian approval for Steqeyma (CT-P43). Biocon has also submitted a Canadian regulatory application, following a signed patent settlement and licence agreement with Janssen which enables Biocon to commercialise its ustekinumab biosimilar “Bmab 1200” in Europe, the United Kingdom, Canada and Japan. On 29 August 2024, Biocon Ltd announced that it has signed a patent settlement and licence agreement with Janssen which enables Biocon to commercialise Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in Europe, the United Kingdom, Canada and Japan. Biocon has submitted regulatory applications in each of these jurisdictions. The Biocon-Janssen patent settlement and licence agreement follows the US settlement agreement in February 2024 enabling Biocon to launch Bmab 1200 in the US in February 2025. In May 2024, Biocon announced that the FDA accepted its BLA for Bmab 1200 for review under the 351(k) pathway. Biocon reported in August 2024 year-on-year consolidated revenue growth of 30% for Q2 2024, with its biosimilars business delivering year-on-year growth of 11% compared with the same quarter last year. JAMP recently filed an application in the Canadian Competition Tribunal seeking leave to bring an action under the Competition Act regarding Stelara® (ustekinumab). JAMP alleges that Janssen has abused its dominant market position, in contravention of section 79 of the Competition Act by “…gam[ing] the pharmaceutical regulatory system and use[ing] sham litigation to disincentivize rivals from launching their own ustekinumab drugs”. If JAMP succeeds in its leave application, it intends to seek a range of orders designed to curb Janssen’s alleged anti-competitive conduct as well as an order for a monetary penalty 3 times the value of the benefit which Janssen has derived from alleged anti-competitive conduct, estimated by JAMP to be at least $1 trillion. In March this year, JAMP launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada. The Alvotech-developed Jamteki™ was approved by Health Canada in November 2023. The March 2024 launch followed a settlement between Alvotech and J&J in February 2024 regarding ustekinumab. On 31 July 2024, Celltrion reported that Health Canada has approved its new drug licence application for Steqeyma (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab), for plaque psoriasis, psoriatic arthritis, and Crohn’s disease. The Health Canada approval follows EMA’s recommendation for European marketing authorisation for Steqeyma and Celltrion’s earlier approval for Steqeyma in Korea on 12 June 2024. Celltrion is also seeking approval for Steqeyma in the United States and Australia, submitting applications with FDA in June 2023, and TGA in April 2023. On 18 March 2024 Fresenius Kabi and Formycon announced they reached a settlement with Johnson & Johnson regarding the commercialisation of FYB202, biosimilar to J&J’s Stelara® (ustekinumab) in Europe and Canada. The announcements did not disclose the permitted launch dates for FYB202 in those regions. In August 2023 the companies announced they had reached a settlement in the US with Johnson & Johnson for FYB202, enabling US launch “no later than 15 April 2025”. Amgen announced that Wezlana™ (ustekinumab injection) and Wezlana™ (ustekinumab for injection, solution for intravenous infusion), biosimilar to Janssen’s Stelara®, is now available in Canada. Wezlana™ is the first biosimilar to be approved by Health Canada for all Stelara® indications, but the second ustekinumab Canadian launch following the launch of the first ustekinumab biosimilar (Jamteki™) in Canada by JAMP Pharma on 1 March 2024. Jamteki™ was developed by Alvotech and was approved by Health Canada in November 2023. On 1 March 2024, JAMP Pharma announced that it launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada. Jamteki™ was approved by Health Canada in November 2023 and JAMP’s launch follows a settlement between Alvotech and J&J last month regarding ustekinumab. Jamteki™ was developed by Alvotech and is JAMP Pharma’s second biosimilar launch in Canada in two years, following the Canadian launch of Simlandi® (adalimumab) biosimilar of AbbVie’s Humira® (adalimumab) in 2022. The approved presentations for Jamteki™ are a 45mg/0.5mL and 90mg/mL pre-filled syringe with a passive safety device for subcutaneous injection. On 21 November 2023, the Canadian Federal Court of Appeals dismissed Janssen’s appeal from a decision of the Federal Court upholding Canada’s Office of Submission and Intellectual Property (OSIP) refusal of Janssen’s application to list Canadian Patent 3113837 on the PMNOC register for two supplementary new drug submissions relating to Stelara® (ustekinumab). The Federal Court decision was handed down in July 2023.2025
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Product specific reports based on extracts from our BioBlast® database
aflibercept | Eylea® | Regeneron
bevacizumab | Avastin® | Roche/Genentech
cetuximab | Erbitux® | BMS/Merck
darbepoetin | Aranesp® | Amgen
denosumab | Prolia®/Xgeva® | Amgen
dupilumab | Dupixent® | Sanofi-Aventis
eculizumab | Soliris® | Alexion
filgrastim (GCSF) | Neupogen® | Amgen
golimumab | Simponi® | Janssen
guselkumab | Tremfya® | Janssen
infliximab | Remicade® | Johnson & Johnson
ixekizumab | Taltz® | Eli Lilly
lecanemab | Leqembi® | Eisai/Biogen
liraglutide | Victoza® /Saxenda® | Novo Nordisk
natalizumab | Tysabri® | Biogen/Elan
olaparib | Lynparza® | AstraZeneca/Merck
omalizumab | Xolair® | Genentech / Novartis
pegfilgrastim | Neulasta® | Amgen
pembrolizumab | Keytruda® | Merck
ranibizumab | Lucentis® | Genentech
regdanvimab | Regkirona® | Celltrion
risankizumab | Skyrizi® | AbbVie
rituximab | Rituxan®/MabThera® | Genentech/Biogen
secukinumab | Cosentyx® | Novartis
semaglutide | Wegovy®/Ozempic® | Novo Nordisk
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech
ustekinumab | Stelara® | Johnson & Johnson/Janssen
BioBlast® Editor and Contributing Author
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